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Orally disintegrating tablet of oleanolic acid and its preparation process

An oral disintegrating tablet and oleanolic acid technology, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of inconvenient taking, affect the curative effect, low bioavailability, etc. The effect of taking, easy to pack and carry

Inactive Publication Date: 2005-12-07
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Only oleanolic acid tablets and capsules are currently on the market in my country. Due to the strong hydrophobicity of oleanolic acid, the dissolution rate and dissolution rate of the tablets and capsules are relatively low, which greatly affects its dissolution in the gastrointestinal tract. and absorption, resulting in low bioavailability in the human body, affecting the full play of its curative effect
On the other hand, tablets and capsules need to be taken with water, which is inconvenient for children, the elderly, those with swallowing difficulties, and emergency patients with inconvenient water intake, thus reducing the patient's compliance with medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The preparation formula of the present invention is made up of following components:

[0030] Oleanolic acid 20.0g

[0031] Microcrystalline Cellulose 60.0g

[0032] Mannitol 120.0g

[0033] Cross-linked polyvinylpyrrolidone 12.0g

[0034] Sodium bicarbonate 5.0g

[0035] Citric acid 5.0g

[0036] Aspartame 1.0g

[0037] Mint essence 0.5g

[0038] Orange essence 0.5g

[0039] Micronized silica gel 3.0g

[0040] Magnesium stearate 1.2g

[0041] A total of 1000 pieces were made

[0042] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: Weigh oleanolic acid, microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, sodium bicarbonate, citric acid, aspartame, mint flavor, orange flavor respectively , passed through an 80-mesh sieve and mixed evenly; then mixed with magnesium stearate and micropowder silica gel, sieved and mixed evenly, and ...

Embodiment 2

[0044] The preparation formula of the present invention is made up of following components:

[0045] Oleanolic acid 20.0g

[0046] Fast flowing lactose (Flowlac  ) 150.0g

[0047] Croscarmellose Sodium 12.5g

[0048] Aspartame 1.0g

[0049] Mint essence 0.5g

[0050] Magnesium stearate 1.2g

[0051] A total of 1000 pieces were made

[0052] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: oleanolic acid, fast flow lactose (Flowlac  ), croscarmellose sodium, aspartame and peppermint essence were weighed respectively according to the amount, passed through an 80 mesh sieve and mixed evenly; then mixed with magnesium stearate, sieved and mixed evenly, and then the intermediate was carried out For content determination, directly compress the tablet according to the specified amount to obtain an orally disintegrating tablet.

Embodiment 3

[0054] The preparation formula of the present invention is made up of following components:

[0055] Oleanolic acid 20.0g

[0056] Microcrystalline Cellulose 100.0g

[0057] Mannitol 100.0g

[0058] Aspartame 1.0g

[0059] Mint essence 0.5g

[0060] Lemon essence 0.5g

[0061] Micronized silica gel 3.0g

[0062] Magnesium stearate 1.2g

[0063] A total of 1000 pieces were made

[0064] The dosage form is prepared by direct compression technology using conventional tablet pharmaceutical equipment. The specific preparation method is as follows: Weigh oleanolic acid, microcrystalline cellulose, mannitol, aspartame, mint flavor, and lemon flavor respectively according to the amount, pass through an 80-mesh sieve and mix evenly; then mix with stearic acid Magnesium and micropowder silica gel are mixed, sieved and mixed evenly, and then the content of this intermediate is determined, and it is directly compressed into tablets according to the specified amount to obtain orally ...

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Abstract

The invention provides an orally disintegrating tablet of oleanolic acid and its preparation process, wherein the formula of the orally disintegrating tablet includes micronized oleanolic acid, bulking agent, crumbling agent, effervescent agent, flavoring agent, lubricating agent and flow aid, and a direct tabletting process is employed. The invention realizes simple process for manufacturing, easy administration, quick disintegration or dissolution in oral cavity, quick effect, substantially increased dissolution and biological availability, thus is especially suitable for the elderly, children or patients of acute diseases with inconvenience of moving or dysphagia or inaccessibility to water.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to an orally disintegrating tablet suitable for treating acute and chronic hepatitis, in particular to an orally disintegrating tablet of oleanolic acid and a preparation method thereof. Background technique [0002] Oleanolic acid (OA) is a pentacyclic triterpenoid compound widely distributed in the plant kingdom and is a chemical component of natural products. This product has a certain protective effect on liver injury, can reduce the elevated serum alanine aminotransferase, promote liver cell regeneration, and accelerate the repair of necrotic tissue. It is an ideal drug for treating acute icteric hepatitis and chronic viral hepatitis, and has low toxicity and few side effects. [0003] Only oleanolic acid tablets and capsules are currently on the market in my country. Due to the strong hydrophobicity of oleanolic acid, the dissolution rate and dissolution rate of the tablets and ca...

Claims

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Application Information

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IPC IPC(8): A61K31/56
Inventor 张文伟郭殿武谢纲郑文严易青
Owner HANGZHOU MINSHENG PHARM CO LTD
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